Tissue connector apparatus and methods

ABSTRACT

Tissue connector assemblies having at least two piercing members, each releaseably coupled to a surgical fastener such as a surgical clip. A flexible member such as a suture may be used to couple one or both piercing members to respective ends of the fastener.

FIELD OF THE INVENTION

The present invention relates to instruments and methods for connectingbody tissues, tissue and prostheses, tissue and graft or any combinationthereof.

BACKGROUND OF THE INVENTION

Minimally invasive surgery has allowed physicians to carry out manysurgical procedures with less pain and disability than conventional,open surgery. In performing minimally invasive surgery, the surgeonmakes a number of small incisions through the body wall to obtain accessto the tissues requiring treatment. Typically, a trocar, which is apointed, piercing device, is delivered into the body with a cannula.After the trocar pierces the abdominal or thoracic wall, it is removedand the cannula is left with one end in the body cavity, where theoperation is to take place, and the other end opening to the outside. Acannula has a small inside diameter, typically 5-10 millimeters, andsometimes up to as much as 20 millimeters. A number of such cannulas areinserted for any given operation.

A viewing instrument, typically including a miniature video camera oroptical telescope, is inserted through one of these cannulas and avariety of surgical instruments and refractors are inserted throughothers. The image provided by the viewing device may be displayed on avideo screen or television monitor, affording the surgeon enhancedvisual control over the instruments. Because a commonly used viewinginstrument is called an “endoscope,” this type of surgery is oftenreferred to as “endoscopic surgery.” In the abdomen, endoscopicprocedures are commonly referred to as laparoscopic surgery, and in thechest, as thoracoscopic surgery. Abdominal procedures may take placeeither inside the abdominal cavity (in the intraperitoneal space) or ina space created behind the abdominal cavity (in the retroperitonealspace). The retroperitoneal space is particularly useful for operationson the aorta and spine, or abdominal wall hernia.

Minimally invasive surgery has virtually replaced open surgicaltechniques for operations such as cholecystectomy and anti-refluxsurgery of the esophagus and stomach. This has not occurred in eitherperipheral vascular surgery or cardiovascular surgery. An important typeof vascular surgery is to replace or bypass a diseased, occluded orinjured artery. Arterial replacement or bypass grafting has beenperformed for many years using open surgical techniques and a variety ofprosthetic grafts. These grafts are manufactured as fabrics (often fromDACRON® (polyester fibers) or TEFLONS® (fluorocarbon fibers)) or areprepared as autografts (from the patient's own tissues) or heterografts(from the tissues of animals) or a combination of tissues,semi-synthetic tissues and or alloplastic materials. A graft can bejoined to the involved artery in a number of different positions,including end-to-end, end-to-side, and side-to-side. This attachmentbetween artery and graft is known as an anastomosis. Constructing anarterial anastomosis is technically challenging for a surgeon in opensurgical procedures, and is almost a technical impossibility usingminimally invasive techniques.

Many factors contribute to the difficulty of performing arterialreplacement or bypass grafting. See generally, Wylie, Edwin J. et al.,Manual of Vascular Surgery, (Springer-Verlag New York), 1980. One suchfactor is that the tissues to be joined must be precisely aligned withrespect to each other to ensure the integrity and patency of theanastomosis. If one of the tissues is affixed too close to its edge, thesuture can rip through the tissue and impair both the tissue and theanastomosis. Another factor is that, even after the tissues are properlyaligned, it is difficult and time consuming to pass the needle throughthe tissues, form the knot in the suture material, and ensure that thesuture material does not become tangled. These difficulties areexacerbated by the small size of the artery and graft. The arteriessubject to peripheral vascular and cardiovascular surgery typicallyrange in diameter from several millimeters to several centimeters. Agraft is typically about the same size as the artery to which it isbeing attached. Another factor contributing to the difficulty of suchprocedures is the limited time available to complete the procedure. Thetime the surgeon has to complete an arterial replacement or bypass graftis limited because there is no blood flowing through the artery whilethe procedure is being done. If blood flow is not promptly restored,sometimes in as little as thirty minutes, the tissue the artery suppliesmay experience significant damage, or even death (tissue necrosis). Inaddition, arterial replacement or bypass grafting is made more difficultby the need to accurately place and space many sutures to achieve apermanent hemostatic seal. Precise placement and spacing of sutures isalso required to achieve an anastomosis with long-term patency.

Highly trained and experienced surgeons are able to perform arterialreplacement and bypass grafting in open surgery using conventionalsutures and suturing techniques. A suture has a suture needle that isattached or “swaged on” to a long, trailing suture material. The needlemust be precisely controlled and accurately placed through both thegraft and artery. The trailing suture material must be held with propertension to keep the graft and artery together, and must be carefullymanipulated to prevent the suture material from tangling. In opensurgery, these maneuvers can usually be accomplished within thenecessary time frame, thus avoiding the subsequent tissue damage (ortissue death) that can result from prolonged occlusion of arterial bloodflow.

A parachuting technique may be used to align the graft with the arteryin an end-to-side anastomosis procedure. One or multiple sutures areattached to the graft and artery and are used to pull or “parachute” thegraft vessel into alignment with an opening formed in a sidewall of theartery. A drawback to this procedure is the difficulty in preventing thesuture from tangling and the time and surgical skill required to tieindividual knots when using multiple sutures. Due to space requirements,this procedure is generally limited to open surgery techniques.

The difficulty of suturing a graft to an artery using minimally invasivesurgical techniques has effectively prevented the safe use of thistechnology in both peripheral vascular and cardiovascular surgicalprocedures. When a minimally invasive procedure is done in the abdominalcavity, the retroperitoneal space, or chest, the space in which theoperation is performed is more limited, and the exposure to the involvedorgans is more restricted, than with open surgery. Moreover, in aminimally invasive procedure, the instruments used to assist with theoperation are passed into the surgical field through cannulas. Whenmanipulating instruments through cannulas, it is extremely difficult toposition tissues in their proper alignment with respect to each other,pass a needle through the tissues, form a knot in the suture materialonce the tissues are aligned, and prevent the suture material frombecoming tangled. Therefore, although there have been isolated reportsof vascular anastomoses being formed by minimally invasive surgery, nosystem has been provided for wide-spread surgical use which would allowsuch procedures to be performed safely within the prescribed timelimits.

As explained above, anastomoses are commonly formed in open surgery bysuturing together the tissues to be joined. However, one known systemfor applying a clip around tissues to be joined in an anastomosis isdisclosed in a brochure entitled, “VCS Clip Applier System”, publishedin 1995 by Auto Suture Company, a Division of U.S. Surgical Corporation.A clip is applied by applying an instrument about the tissue in anonpenetrating manner, i.e., the clip does not penetrate through thetissues, but rather is clamped down around the tissues. As previouslyexplained, it is imperative in forming an anastomosis that tissues to bejoined are properly aligned with respect to each other. The disclosedVCS clip applier has no means for positioning tissues. Before the clipcan be applied, the tissues must first be properly positioned withrespect to each other, for example by skewering the tissues with aneedle as discussed above in common suturing techniques or with forcepsto bring the tissues together. It is extremely difficult to perform suchpositioning techniques in minimally invasive procedures.

Therefore, there is currently a need for other tissue connectingsystems.

SUMMARY OF THE INVENTION

The present invention involves apparatus and methods for connectingmaterial, at least one of which is tissue. The invention may, forexample, be used to secure one vessel to another, such as in a vascularanastomosis.

According to one aspect of the invention, a tissue connector assembly isprovided comprising a surgical fastener, such as a surgical clip, afirst tissue piercing member and a second tissue piercing member. Thefastener may be adapted to assume a loop configuration. The fastener hasa first end portion and a second end portion. The first tissue piercingmember is coupled to the first end portion and the second tissuepiercing member is coupled to the second end portion. The multiplepiercing member construction facilitates threading ends of the assemblyfrom inner to outer walls of material, such as tissue, which mayeliminate or minimize the possibility of dislodging material from theinner wall of a vessel, for example.

According to another aspect of the invention, a flexible member, such asa suture, may be provided between at least one piercing member and thefastener to facilitate threading the fastener and/or “parachute”techniques, for example.

According to another aspect of the invention, synchronized piercingmember release mechanisms may be provided. In one embodiment, the tissueconnector assembly may include a first coupling, which couples the firsttissue piercing member and first end portion of the surgical fastener,and a second coupling, which couples the surgical fastener second endportion and second piercing member. The first coupling releases theother coupling in response to releasing the first coupling. According toone aspect of this embodiment, multiple tissue piercing members may bedecoupled from the surgical fastener with one release actuator.According to another aspect, the piercing members may be decoupledessentially simultaneously.

The above is a brief description of some deficiencies in the prior artand advantages of the present invention. Other features, advantages, andembodiments of the invention will be apparent to those skilled in theart from the following description, accompanying drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of a tissue connector assembly constructed inaccordance with the principles of the present invention;

FIG. 2A is a partial sectional view illustrating an alternateconstruction of flexible member 18 of FIG. 1;

FIG. 2B is a partial sectional view illustrating yet anotherconstruction of flexible member 18 of FIG. 1;

FIGS. 3A, 3B and 3C show a fastener which can be used with the tissueconnector assembly of FIG. 1, where FIG. 3A is a top view of thefastener in a closed position, FIG. 3B is a side view of the fastener ofFIG. 3A, and FIG. 3C is an enlarged view of the fastener of FIG. 3A inan open position;

FIG. 4 is a top view of another fastener configuration, which can beused with the tissue connector assembly of FIG. 1;

FIGS. 5A and 5B show yet another fastener configuration which can beused with the tissue connector assembly of FIG. 1, where FIG. 5A showsthe fastener in a closed position and FIG. 5B is a side view of thefastener of FIG. 5A;

FIG. 6 is top view of yet a further configuration of a fastener that canbe used with the tissue connector assembly of FIG. 1 with the fastenerin a closed position;

FIGS. 7A, 7B and 7C illustrate a release mechanism which can be usedwith any of the fasteners described above and the tissue connectorassembly of FIG. 1, where FIG. 7A shows the restraining device incross-section and in a locked position, FIG. 7B is a transversecross-sectional view of the restraining device taken in a plane alongline 7B—7B of FIG. 7A, and FIG. 7C is a cross-sectional view of therestraining device of FIG. 7A in an unlocked position;

FIGS. 8A, 8B and 8C illustrate another release mechanism which can beused with any of the fasteners described above and the tissue connectorassembly of FIG. 1, where FIG. 8A shows the restraining device incross-section and in a locked position, FIG. 8B is a transversecross-sectional view of the restraining device taken in a plane alongline 8B—8B of FIG. 8A, and FIG. 8C is a cross-sectional view of therestraining device of FIG. 8A in an unlocked position;

FIGS. 9A-9F illustrates yet another release mechanism which can be usedwith any of the fasteners described above, where FIG. 9A shows aperspective view of the retaining device coupled with a fastener, FIG.9B is a sectional view of the retaining device of FIG. 9A, FIG. 9C is atransverse cross-sectional view of the restraining device taken alongline 9C—9C in FIG. 9B, FIGS. 9D and 9E are perspective and end views ofthe restraining device, respectively, showing the device depressed forrelease of the fastener; and FIG. 9F shows the retaining device of FIG.9A with an adapter for coupling to the other end of the fastener;

FIGS. 10A-10C show a synchronized fastener release system, where FIGS.10A and 10C are partial sectional views of the system in a coupled anddecoupled state, respectfully, and FIG. 10B is a sectional view takenalong lines 10B—10B in FIG. 10A;

FIGS. 10D-10F show another synchronized fastener release system whereFIGS. 10D and 10E are partial sectional views of the system in a coupledand decoupled state, respectfully, and FIG. 10F is a transversecross-sectional view taken along line 10F—10F in FIG. 10E;

FIGS. 11A and 11B are partial sectional views of another piercing memberand/or suture release mechanism in a coupled and decoupled state,respectfully;

FIGS. 12A and 12B are partial sectional views of a further piercingmember and/or suture release mechanism in a coupled and decoupled state,respectfully;

FIGS. 13A and 13B are partial sectional views of yet another piercingmember and/or suture release mechanism in a coupled and decoupled state,respectfully;

FIG. 14A is a front view of a another embodiment of a tissue connectorassembly of the present invention;

FIG. 14B is a sectional view of a piercing member and release mechanismcombination, which can be used in the embodiment, illustrated in FIG.14A;

FIG. 15 is a front view of a lateral tissue connector, which can be usedin conjunction with any of the assemblies described above;

FIGS. 16A-16D diagrammatically illustrate a method of aligning andconnecting graft and target vessels with the tissue connector assemblyof FIG. 1, where FIG. 16A shows two such tissue connector assembliesthreaded through a graft and target vessel, FIG. 16B shows a furtherstep in connecting the graft and target vessel with the tissue connectorassembly fastener is positioned in the target vessel, FIG. 16C shows yeta further step where the graft has been brought into position over theopening formed in the target vessel and the tissue connector assemblyfastener positioned through the walls of the graft and target vessel andFIG. 16D shows the fasteners released from the tissue connector assemblyof FIG. 1 and securing the graft and target vessel together withadditional laterally disposed fasteners;

FIG. 16E is a partial sectional view of the graft and target vesselswith the tissue connector assembly fasteners of FIG. 1 in place prior toplacement of additional lateral fasteners; and

FIG. 16F is an enlarged view of the tissue connection within line 16F ofFIG. 16E.

Corresponding reference characters indicate corresponding elementsthroughout the drawings.

DESCRIPTION OF THE INVENTION

The present invention generally involves methods and devices formanipulating, aligning and/or connecting tissues, tissue and prosthesis,tissue and graft, or any combination thereof. As used herein, the termgraft includes any of the following: homografts, autologous grafts,xenografts, allografts, alloplastic materials, and combinations of theforegoing. Tissue connector assemblies are disclosed, which, forexample, may be used in vascular surgery to replace or bypass adiseased, occluded, or injured artery by connecting a graft vessel to acoronary artery or vein in an anastomosis as shown in FIGS. 16A-F.Assemblies constructed in accordance with the invention may be used inopen surgical procedures or in minimally invasive or endoscopicprocedures for attaching tissue located in the chest, abdominal cavity,or retroperitoneal space. It should be understood, however, that theseexamples are provided for illustration and are not intended to limit thescope of the invention.

Tissue connecting assemblies and methods are disclosed in copending U.S.patent application Ser. Nos. 09/089,884 and 09/090,305, both entitledTissue Connector Apparatus and Methods and having a filing date of Jun.3, 1998. The entirety of the disclosures of the cited '884 and '305applications is hereby incorporated herein. One aspect of the presentinvention is the provision of multiple tissue piercing members. Morespecifically, tissue connecting assemblies constructed according to thepresent invention generally include a plurality of tissue piercing orpenetrating members coupled to a surgical fastener. The multiplepiercing member construction facilitates threading ends of the assemblyfrom inner to outer wall(s) of material, such as tissue, which mayeliminate or minimize the possibly of dislodging material, such asplaque, from the inner wall of calcified arteries, for example, as willbecome more apparent from the description provided below. In a preferredembodiment, two piercing members, each of which may comprise a needle,are releaseably coupled to a fastener. One or both of the piercingmembers may be attached to a flexible member, such as a suture, which inturn is releaseably coupled to the fastener. Double and single flexiblemember embodiments are illustrated in FIGS. 1 and 14, respectively. Thecoupling between the flexible member (and, thus, the piercing member)and the fastener may be constructed to actuate closure of the fastenerupon release of the flexible member (or piercing member). For example,the coupling may hold a compression spring (which is positioned around afastener) in a compressed state to brace the fastener open andreleaseably lock or secure the fastener to the flexible member (orpiercing member).

FIG. 1 illustrates one embodiment of a tissue connector assembly inaccordance with the present invention. Referring to FIG. 1, a tissueconnector assembly 11, which generally comprises tissue piercing orpenetrating members 16 and 17, flexible members 18 and 19, and afastener 20 (e.g., a surgical clip) is shown. A restraining device,generally indicated at 24 and comprising a spring (or coil) 26 and alocking device (or coupling member) generally indicated at 28, isconnected to fastener 20 for holding the fastener in a deformed or openconfiguration as will be further described below. Although a particularfastener and accompanying restraining device is shown in FIG. 1, itshould be understood that any suitable fastener can be used, includingbut not limited to the alternate fastener configurations describedbelow. For example, the fastener may be a plastically deformable clip ormay comprise two or more parts, at least one of which is movablerelative to the other part, such as with a hinged clip. Further, otherpiercing member release mechanisms can be used with or withoutrestraining devices depending on the fastener construction.

Each of penetrating or piercing members 16 and 17 may be in the form ofa needle (such as a 7-0 or 8-0 needle) having a sharp pointed tip (30 or31) at its distal end for penetrating tissue. Members 16 and 17 may bebent as shown in FIG. 1, for example. The diameter of at least a portionof each of members 16 and 17 is preferably greater than the diameter ofthe respective flexible members (18 and 19), coupled thereto so that theflexible members can easily be pulled through an opening formed in thetissue (or other material) by the needle. The distal ends of the members16 and 17 are preferably rigid to facilitate penetration of tissue. Theremaining length of members 16 and 17 may be rigid or flexible tofacilitate movement of the needle through the tissue as furtherdescribed below. Tips 30 and/or 31 may have various configurations andmay, for example, be conical, tapered, or grounded to attain a three orfour facet tip. Members 16 and 17 may be made from stainless steel orany other suitable material, such as a polymeric material. It is to beunderstood that members 16 and 17 may have a shape or radius ofcurvature other than the one shown, without departing from the scope ofthe invention. Members 16 and 17 may also be integrally formed with theflexible member 18 (e.g., both piercing member and flexible memberformed of the same material).

The flexible members 18 and 19 may be in the form of a suture formedfrom conventional filament material, metal alloy, such as nitinol,polymeric material, or any other suitable material. The material may benon-stretchable or stretchable, solid or hollow (as shown, for example,in FIGS. 2A and 2B), and have various cross-sectional diameters. Theflexible members or sutures may have a cross-sectional diameter of 0.003inch, for example. The diameter and length of the suture will varydepending on the specific application. The sutures may be attached tothe piercing members 16 and 17, respectively, by crimping or swaging thepiercing member or needle onto the suture, gluing the suture to thepiercing member or needle, or any other suitable attachment method.Flexible members 18 and 19 may have cross-sectional shapes other thanthe one shown herein and may have other constructions as well.

Referring to FIG. 2A, an alternate flexible member construction isshown. Flexible member 18′ generally comprises a flexible filament 14,which may be in the form of a metal wire, and tube or sleeve 15, whichmay be in the form of a hollow suture. Tube 15 surrounds filament 14with one end of the filament 14 secured to piercing member 16 and itsother end secured to coupling 28 with glue, for example. The filamentmay provide kink resistance and pull strength (to minimize or eliminatestretch), and is especially advantageous when using very thin materialfor tube 15. Tube 15 may, for example, comprise polymeric materials suchas polyurethane or polyester. It is noted that at least the portions ofthe tube adjacent to needle 16 and coupling 28 have the same diameter asthe portions of the coupling and needle adjacent thereto. Thiseliminates the need for the tapered portions 2 and 3 shown in FIG. 1 orother transition sections to minimize or eliminate the step between theflexible member and needle and/or the flexible member and the coupling.Of course, the diameter of the entire flexible member may be the same asthat of the coupling and the portion of the needle adjacent to theflexible member as indicated in FIG. 2A. It also should be apparent fromthe foregoing that the construction of flexible member 18′ may besubstituted for flexible member 19.

Referring to FIG. 2B, another hollow flexible member construction isshown. Flexible member 18″ comprises tube or sleeve 15, which may be inthe form of a hollow suture. Tube 15 is secured to piercing member orneedle 16 and coupling 28 through posts or anchors 4, which in turn, aresecured to piercing member or needle 16 and coupling 28. The relativedimensions of tube 15 as compared to needle 16 and coupling 28 may bethe same as those describe in connection with FIG. 2A for the samereasons. Further, flexible member 18″ may be substituted for flexiblemember 19 as well.

Referring to FIGS. 3-6, fasteners, which were shown in copending U.S.patent application Ser. Nos. 09/089,884 and 09/090,305 and which may beused in the present invention, first will be described. Referring toFIGS. 3A-C, one embodiment of a fastener (e.g., fastener 20) comprises adeformable wire 34 made of a shape memory alloy. A nickel titanium(nitinol) based alloy may be used, for example. The nitinol may includeadditional elements which affect the yield strength of the material orthe temperature at which particular pseudoelastic or shapetransformation characteristics occur. The transformation temperature maybe defined as the temperature at which a shape memory alloy finishestransforming from martensite to austenite upon heating (i.e., A_(f)temperature). The shape memory alloy preferably exhibits pseudoelastic(e.g., superelastic) behavior when deformed at a temperature slightlyabove its transformation temperature. At least a portion of the shapememory alloy is converted from its austenitic phase to its martensiticphase when the wire is in its deformed configuration. As the stress isremoved, the material undergoes a martensitic to austenitic conversionand springs back to its original undeformed configuration. When the wireis positioned within the tissue in its undeformed configuration, aresidual stress is present to maintain the tissue tightly together (seee.g., FIG. 16F). In order for the pseudoelastic wire 34 to retainsufficient compression force in its undeformed configuration, the wireshould not be stressed past its yield point in its deformedconfiguration to allow complete recovery of the wire to its undeformedconfiguration. The shape memory alloy is preferably selected with atransformation temperature suitable for use with a stopped heartcondition where cold cardioplegia has been injected for temporaryparalysis of the heart tissue (e.g., temperatures as low as 8-10 degreesCelsius).

It is to be understood that the shape memory alloy may also be heatactivated, or a combination of heat activation and pseudoelasticproperties may be used, as is well known by those skilled in the art.

The cross-sectional diameter of wire 34 and length of the wire will varydepending on the specific application. The diameter “d” of wire 34 maybe, for example, between 0.001 and 0.015 inch. For coronary bypassapplications, the diameter is preferably between 0.001 and 0.008 inchwith a diameter “D” of the loop (FIG. 3A) being between 0.0125 and0.0875 inch. As shown in FIG. 3A and 3B, wire 34 may have a circularcross-sectional shape and a generally ring or loop shaped configurationwhen in a closed position. The diameter “D” of the loop of the fastener20 (with coil 26, which may be platinum) in its closed position ispreferably sized to prevent movement between adjacent tissues. It is tobe understood, however, that the wire may have other cross-sectionalshapes such as rectangular, or may be formed from multiple strandswithout departing from the scope of the invention.

One end of wire 34, which may be referred to as the proximal end of wire34, may include an enlarged portion 36 having a cross-sectional areagreater than the cross-sectional area of the wire to resist the coilfrom passing thereover. The enlarged portion 36 also may be provided tocooperate with a release mechanism as will be discussed in more detailbelow. Enlarged portion 36 may be formed by attaching a member to theend of wire 34 by welding, gluing or other suitable attachment means ormay be formed integrally with the wire by deforming the end of the wire.The other end of wire 34, which may be referred to as the distal end ofwire 34, also may include an enlarged portion 38 for engagement with arestraining device, such as restraining device 24 (see. e.g., FIG. 1),or a locking device or release mechanism, such as release mechanism 28(see e.g., FIG. 1), as further described below. The enlarged portion 38may be formed by deforming the end of the wire 34 by swaging or arcwelding, or attaching an enlarged portion to the end of the wire bywelding, swaging, or other suitable means. Although enlarged portions 36and 38 are shown with spherical and cylindrical configurations, otherconfigurations or configuration combinations can be used. For example,both enlarged portions may be spherical or cylindrical, or portion 36may be cylindrical and portion 38 spherical.

Referring to FIGS. 3A-C, fastener 20 is shown in open and closedconfigurations. When wire 34 is in an undeformed or closedconfiguration, the fastener is closed (as shown in FIGS. 3A and 3B) forkeeping or connecting tissue together, and when wire 34 is in a deformedor open configuration, the fastener is open (as shown in FIG. 3C) forinsertion of the wire into tissue. As discussed above, wire 34 is in itsclosed configuration when in a relaxed state. Wire 34 is preferably notdeformed past its yield point in its open position. Accordingly, it mayhave a U-shaped configuration in its open position to facilitateinsertion of the wire through the tissue. It is to be understood thatU-shaped configuration may be alternatively substituted by an equivalentstructure such as C-shaped, V-shaped, J-shaped, and other similarlyshaped configurations. Wire 34 is moved from its closed position to itsopen position by a restraining device, as further described below. Whenin its closed position, wire 34 forms a loop with the ends of the wirein a generally side-by-side or overlapping orientation (FIG. 3B).

Wire 34 may be formed in the above described shape by first wrapping thewire onto a mandrel and heat treating the wire at approximately 400-500degrees Celsius for approximately 5 to 30 minutes. Wire 34 is then airquenched at room temperature. The mandrel may have a constant diameteror may be conical in shape.

Referring to FIG. 4, an alternate configuration of fastener 20 in itsclosed position is shown, and generally indicated with reference numeral40. Fastener 40 forms a spiral configuration in its closed position fortrapping the tissue within a loop formed by the spiral. In its openposition, the fastener 40 is configured to form less than a full 360degree turn, and may be made to have an open position as shown in FIG.3C, for example.

Referring to FIGS. 5A and 5B, another configuration of fastener 20 isshown in its closed position, and is generally designated with referencenumeral 41. Fastener 41 is formed in a spiral about a centrallongitudinal axis A. As shown in FIG. 5B, fastener 41 has a generallyconical shape along the longitudinal axis A, with a decreasing diameteras the radius of curvature of fastener 41 decreases. Fastener 41 has aninner end portion 45 and an outer end portion 47, with the enlargedportion 38 of the wire being disposed at the outer end portion forengagement with the restraining device 24 as shown, for example, in FIG.3C.

Referring to FIG. 6, a modification of fastener 41 is shown, andgenerally indicated with reference numeral 43. Fastener 43 is similar tofastener 41 described above, except that enlarged portion 38, which isadapted for engaging a restraining device or releasable lockingmechanism, is positioned at the inner end portion 45 of the fastener.Placement of restraining device 24 at the inner end portion 45 offastener 43 increases the compression force of the wire in itsundeformed position on the tissue and decreases the surface area of thefastener exposed to blood flow.

It is to be understood that the fasteners may have undeformed ordeformed configurations different than those shown herein withoutdeparting from the scope of the invention. In addition, a locking clip(not shown) may also be attached to connect the ends of the fastener(such as fastener 20, 40, 41, 43) when the fastener is in its closedposition to prevent possible opening of the fastener over time. Thelocking clip may also be integrally formed with one end of the fastener.

As shown in FIG. 3C, wire 34 is surrounded by spring or coil 26 which,along with the locking device 28, restrains the wire in its deformedconfiguration. Coil 26 comprises a helical wire forming a plurality ofloops which define a longitudinal opening 44 for receiving the shapememory alloy wire 34. Coil 26 may be formed from a platinum alloy wirehaving a cross-sectional diameter of approximately 0.0005-0.005 inch,for example. The helical wire may have other cross-sectional shapes andbe formed of different materials. Coil 26 is preferably sized so thatwhen in its free (uncompressed state) it extends the length of wire 34with one end adjacent the enlarged portion 36 at the proximal end of thewire and the other end adjacent enlarged portion 38 at the distal end ofthe wire. It is to be understood that the coil may not extend the fulllength of the wire. For example, a flange or similar device may beprovided on an intermediate portion of wire 34 to limit movement of thecoil along the length of the wire.

When coil 26 is in its free state (with the wire in its undeformedconfiguration), loops of the coil are generally spaced from one anotherand do not exert any significant force on the wire 34 (FIGS. 3A and 3B).When the coil 26 is compressed (with the wire 34 in its deformedconfiguration), loops of the coil on the inner portion 46 of the coilare squeezed together with a tight pitch so that the loops arecontiguous with one another while loops on the outer portion 48 of thecoil are spaced from one another (FIG. 3C). This is due to thecompressed inner arc length of coil 26 and the expanded outer arc lengthof the coil. The compression of the loops on the inner portion 46 ofcoil 26 exerts a force on the inner side of wire 34 which forces thewire to spread open (i.e., tends to straighten the wire from its closedconfiguration to its open configuration). The end of coil 26 adjacentenlarged portion 36 is held in a fixed position relative to wire 34. Theopposite end of coil 26 is free to move along wire 34 and is held inplace when the coil is in its compressed position by locking device 28.It should be understood, however, that a coil (not shown) havingsufficient stiffness, for example, may be used where adjacent loops donot contact one another when the coil is compressed to force wire 34into an open position.

Referring to FIGS. 7A-7C, one embodiment of a releaseable locking deviceor release mechanism, which is disclosed in U.S. patent application Ser.Nos. 09/089,884 and 09/090,305, is shown. Releaseable locking device 28a is adapted for releaseably coupling a fastener (such as any of thefasteners shown in FIGS. 3-6) to a flexible member (such as flexiblemember 18, 18′ or 18″) is shown and generally designated with referencenumeral 28 a. Release mechanism 28 a comprises a flexible tubular member50 having a distal end portion 52 and is shown with tapered section orsleeve 2, which in turn is coupled to the flexible member. Taperedsection or sleeve 2, which provides a transition between the flexiblemember and fastener for insertion of the fastener through tissue, may bea separate member coupled to tubular member 50 or be formed integrallytherewith. Tubular member 50 further includes a proximal end portion 54releasably attached to wire 34. In this manner, release mechanism 28 areleaseably couples the flexible member and needle to the surgicalfastener such as fastener 20. In addition to releasably coupling theflexible member and needle to the fastener, the locking device orrelease mechanism compresses coil 26 to bias the fastener or surgicalclip 20 in its open configuration to facilitate insertion of the lockingdevice 28 through tissue. Although a straight tapered section is shown,it may be curved as well. Tapered portion 2 may be formed from a metalalloy such as stainless steel or a suitable polymeric material and maybe solid or in the form of a sleeve as noted above. Generally, taperedsection 2 gradually diminishes in diameter to provide a smooth,non-stepped transition between the relatively small diameter of theflexible member to the larger diameter of locking device such as lockingdevice 28 a. The flexible member such as flexible member 18 may beswaged into the tapered section, or a heat shrink plastic covering mayhold the flexible member in place. The locking device may also becurved.

Tubular member 50 is movable between a locked position (FIGS. 7A and 7B)for holding coil 26 in its compressed position and wire 34 in itsdeformed position, and an unlocked position (FIG. 7C) for inserting orreleasing the wire and coil. Referring to FIGS. 7B and 7C, three slots58 are shown formed in tubular member 50 extending from the proximal end54 of the member and along at least a portion of the member. Slots 58are provided to allow the proximal end 54 of tubular member 50 to openfor insertion and removal of the wire 34. It is to be understood thatthe number of slots 58 and configuration of the slots may vary, ortubular member 50 may be formed to allow expansion of proximal end 54without the use of slots.

Proximal end 54 of tubular member 50 includes a bore 62 having adiameter slightly greater than the outer diameter “d” of wire 34, butsmaller than the diameter of enlarged portion 38 at the distal end ofthe wire and the outer diameter of the coil 26. Bore 62 extends into acavity 64 sized for receiving the enlarged portion 38 of wire 34.Tubular member 50 may be described as having an annular flange 61 forreleasably securing enlarged portion 38. As shown in FIG. 7C, uponapplication of an inwardly directed radial squeezing force on thetubular member 50 proximal end 54 of the tubular member is opened toallow for insertion or removal of wire 34. When the force is released,the tubular member 50 moves back to its locked position and securelyholds wire 34 in place and compresses the coil 26 as shown in FIG. 7A. Adisc 51 may be inserted into tubular member 50 to act as a fulcrum andcause the proximal end 54 of the tubular member to open. Alternatively,disc 51 may be integrally formed with tubular member 50. As shown inFIG. 7A, the length l of the bore 62 or flange 61 determines the amountof compression of the coil, which in turn determines the amount ofdeformation of wire 34. The greater the length l of bore 62, the greaterthe compression of coil 26 and the more straightening of wire 34 willundergo. The compression of coil 26 is preferably limited so that wire34 is not stressed beyond its yield point. This allows wire 34 to revertback to its original undeformed configuration and apply sufficientpressure to hold the connected tissue together.

FIGS. 8A, 8B and 8C illustrate another release mechanism which isgenerally designated with reference numeral 28 b. FIGS. 8A and 8B showthe release mechanism in a locked position, and FIG. 8C shows therelease mechanism in an unlocked position. Release mechanism 28 bcomprises a tubular member 80, which has proximal and distal ends 88 and89, respectively. Tubular member 80 further includes bore 82 formedtherein and a cavity or recess 84 extending radially outward from bore82 into the tubular member. Recess 84 is configured to receive enlargedportion 38 or wire 34 as best illustrated in FIG. 8A. Recess 84 and bore82 form an annular flange 86, which has an inner diameter less than thatof enlarged portion 38 and, thus, resists removal of the enlargedportion. In the embodiment shown in FIGS. 8A-C, three slots 87 areformed in tubular member 80 as in the embodiment shown in FIGS. 7A-C.The slots extend longitudinally from the proximal end 88 of tubularmember 80 and form fingers 81, which radially expand and release wire 34upon radial compression of the tubular member as shown in FIG. 8C and asdescribed above in connection with release mechanism 28 a. In thisembodiment, however, enlarged portion 38 forms a fulcrum. Although threeequiangularly spaced slots, which extend parallel to the longitudinalaxis are shown as in release mechanism 28 a, the number andconfiguration of the slots may vary, or the tubular member may be formedto allow expansion of the proximal end portion without the use of slots.A tapered section 2 also may be provided as described above inconnection with release mechanism 28 a.

FIGS. 9A-9E illustrate yet another release mechanism which is disclosedin U.S. patent application Ser. No. 09/259,705 entitled Tissue ConnectorApparatus With Cable Release and filed on even date herewith. Therelease mechanism is generally indicated with reference numeral 28 c inFIGS. 9A-9E where FIGS. 9A-C show the mechanism coupled with a fastener,and FIGS. 9D and 9E show the release mechanism depressed for release ofthe fastener. Locking device or release mechanism 28 c comprises aplurality of substantially rigid strands, preferably wires 106, arrangedsubstantially parallel to one another and circularly about alongitudinal axis of the aligned strands, to form a tube-likeconfiguration, as can be seen in the cross-sectional view of FIG. 9C andthe perspective view in FIG. 9A. Alternatively, strands 106 may becables or some other substantially rigid strand elements arranged in thesame manner as the wires shown in FIG. 9C. Upon arrangement into thecircular configuration, the hidden end portions 106 a of the strands arecoupled to tapered section 2, which is coupled to a piercing member orneedle through a flexible member such as flexible member 18.

Preferably, a rod 162 extends from tapered section 2 to facilitatefixation of the strands thereto. The coupling of the strands to taperedsection 2 is preferably accomplished by gluing or soldering to rod 162,although other equivalent or similar known joining techniques may beemployed (e.g. welding, threadably attaching, etc). Similarly, rod 162is preferably glued, soldered or threaded into the needle or transitionelement. In an alternate arrangement, the flexible member may extendthrough tapered section 2 and form a substitute structure for rod 162.This may be preferred when the flexible member is a metal wire.

The end portions 106 b of the strands in the vicinity of the fastenerstrands include notches 109 which are formed into the strands to a depthequal to approximately half the diameter of the strand 106. When thestrands are arranged in the circular configuration described above, thenotches 109 form a chamber 108 configured for receiving and holdingenlarged portion 38. Although enlarged portion 38 is shown as having aspherical shape, it may have other shapes including a barrel shape, orother shape that may be easily grasped and easily released. The notchesare preferably placed about 0.015″ from the free ends of the strands,but this distance, of course, can be modified, depending upon the amountof compression of spring 26 that is desired when ball 38 is insertedinto and held by notches 109.

After placement of ball 38 within chamber 108 formed by notches 109, ashrink wrap layer, preferably a shrink tubing 110 may be provided overat least free end portions 106 b of wires or strands 106, and the tubingheated to compress against strands 106 and hold them in place againstball 38, preferably symmetrically against ball 38. Together, tubing 110and strands 106 effectively hold ball 38 captive within notches 109.Alternatively, other plastic or elastic restraining members may bemounted around the distal portions of the wires or strands to aid inmaintaining them in place, preferably symmetrically against ball 38.Still further, strand members may be designed with an elastic springforce sufficient to maintain notches 109 in place with sufficient forceto maintain the ball 38 captive therein under the tensile forcesnormally experienced during a suturing procedure. Although a sevenstrand embodiment is shown, it should be understood that fewer or morethan seven strands may be used. The number of strands may vary dependingon, for example, the size of the clip or the size of the strands.Typically, the number of strands may range from two to ten. In acoronary anastomosis, the number of strands preferably will range fromfive to seven although other numbers may be used.

In assembling, enlarged portion 38 of wire 34 is placed in chamber 108.Tubing 110 is wrapped around at least a portion of the strands (as shownin the drawings) and heated to maintain enlarged portion 38 captivewithin the cavity formed by the strands. Compression coil or spring 26is slid over wire 34 and compressed against portions 106 b such that thefastener is in its open configuration. Enlarged portion 36 may then beformed or attached to wire 34 to maintain the fastener in its openconfiguration.

Release mechanism 28 c is movable between a locked position (FIGS.9A-9C) and an unlocked position (FIGS. 9E and 9F). In the lockedposition the ball 38 is held within notches 109 and consequently, coil26 is held in its compressed position, thereby maintaining fastener wire34 in its deformed or open position. In the unlocked position, ball 38is released from the notches, thereby allowing the coil 26 to expand,which causes the fastener wire 34 to close. The closure conformation ofthe wire may be characterized by any of those described above withreference to FIGS. 3-6, for example.

Movement of the release mechanism to the open position is accomplishedby applying a compressive force to the shrink tube 110 and bundle ofstrands 106, as shown in FIGS. 9D and 9E. Advantageously, thecompressive force may be applied at any opposing locations around thecircumference of the shrink tube as long as the implement applying theforce is oriented at an angle to the strands, preferably substantiallyperpendicular thereto, to allow the implement to traverse the strands soas to deform the positions thereof when the force is applied. Forexample, needle holder 111 could be rotated 90° (or virtually any otherangle) with respect to the strands 106 as shown in the plane of thedrawing, while retaining the capability of deforming the strands to anopen position upon application of a compressive force. The compressiveforce is preferably applied using a standard needle holder 111 orforceps, although other tools could be used, preferably those withapplicators narrower than the length of the shrink tube 110. As shown,the strands or wires 106 get distorted from their circular configurationunder the compression. This change in shape stretches the shrink tube110 from a circular configuration to a somewhat ellipticalconfiguration, and removes some of the notches 109 from contact withball 38, thereby permitting removal of ball 38 from within the chamberpreviously formed by notches 109 in the closed position.

Referring to FIG. 9F, release mechanism 23 c also may be used toreleasably couple the other end of the fastener to another flexiblemember such as flexible member 19, which in turn, is coupled to a needlesuch as needle 17 as shown in FIG. 1. In this arrangement, a member orstopper 115, which may be annular, is secured to the other end of thefastener or wire 34 to prevent enlarged portion 36 from passing throughthe compression spring upon release from release mechanism 23 c. Otherrelease mechanisms, which provide synchronized release of both needlesillustrated in FIG. 1, also can be used.

FIGS. 10A-10F illustrate synchronized fastener release systems.Referring to FIGS. 10A-10C, a first synchronized release system is shownin a coupled and decoupled state, respectfully. Although one releasemechanism is shown as corresponding to release mechanism 28 c, releasemechanisms 28 a or 28 b or any release mechanism which releaseablycouples the flexible member or needle to the surgical fastener andeffects compression of coil 26 also may be used. At the other end of thefastener or wire 34, a release mechanism which responds to thecompressive state of coil 26 and releases the fastener or wire 34 uponrelease of compressive forces on the coil is shown and generallydesignated with reference numeral 29 a. Release mechanism 29 a comprisestwo members 121 each having a recess 122 formed therein and arranged toform chamber 124 when members 121 are aligned as shown in FIG. 10A.Recesses 122 are configured to retain enlarged portion 36, which isshown with a cylindrical configuration, but may have a spherical orother suitable shape for operatively associating with a suitablyconfigured chamber. Further, members 121 may have semicirculartransverse cross sections or some other combination of transverse shapesthat can collectively provide the desired chamber to retain enlargedportion 36. The number of members 121 also may vary as would be apparentto one of ordinary skill.

Release mechanism members 121 have tapered ends 126, which areconfigured for positioning between coil 26 and fastener wire 34 as shownin FIG. 10A. When tapered ends 126 are so positioned and coil 26 is in acompressed state, coil 26 holds tapered ends 126, which are normallybiased away from each other as shown in FIG. 10C, sufficiently togetherto retain enlarged portion 36 within chamber 124. When release mechanism28 c is actuated (e.g., radially compressed) to release enlarged portion38 of fastener wire 34, coil 26 assumes its relaxed state, therebyreleasing tapered ends 126 of release mechanism 29 a from the coil andallowing the tapered ends to radially expand and release enlargedportion 36 of fastener wire 34 as shown in FIG. 10C. Accordingly, bothneedles and flexible members may be decoupled from the fastener whenrelease mechanism 28 c is actuated.

FIGS. 10D-10F show another synchronized fastener system which is thesame as the system shown in FIGS. 10A-10C with the exception of releasemechanism 29 b and the cooperating portion of the fastener or wire 34being substituted for release mechanism 29 a. In this embodiment, anannular member or stopper 115, which may be annular, is slidably coupledto fastener wire 34. Member 115 is configured to resist passage of coil26 thereover. Accordingly, member 115 may have an outer diameterslightly greater than at least the portion of the coil adjacent thereto.A tapered or frustoconical member 3′ is secured to an end of fastenerwire 34, which need not include an enlarged portion. Member 3′ is thesame as member 3 with the exception that member 3′ has a channel 134 forreceiving flexible member or suture 19. Channel 134 extends radiallyoutward from bore 132, which is formed through member 3′, for receivingthe fastener or wire 34.

Flexible member 19 is threaded through channel 134 and between taperedmember 3′ and annular member 115. When coil 26 is in a compressed stateas shown in FIG. 10D, the coil urges member 115 toward tapered member 3′and compresses flexible member 19 therebetween. In this manner, flexiblemember 19 is secured to the fastener or wire 34. When release mechanism28 c is actuated (e.g., radially compressed) to release enlarged portion38 of the fastener or wire 34, coil 26 assumes its relaxed state so thatannular member 155 may slide away from tapered member 3′ and releaseflexible member 19. Accordingly, both needles and flexible members maybe removed from the fastener when release mechanism 28 c is actuated.Although a metal flexible member may be used, a polymeric flexiblemember may be preferred.

FIGS. 11A and 11B show another release mechanism generally indicatedwith reference numeral 29 c. Release mechanism 29 c includes a sleeve142, which is slidably mounted over flexible member 19 so that it can bepositioned over the flexible member and the fastener or wire toreleaseably hold the flexible member and the fastener together. The endportion of the flexible member opposite the needle and the end portionof the fastener or wire to be engaged therewith may be configured toprovide interlocking engagement therebetween. In the embodiment shown inFIGS. 11A and 11B, the flexible member, which preferably is metal inthis example, and the fastener or wire end portions have mating flangeand groove configurations. Flexible member 19 includes groove 144 a andflange 146 a, which mate with or interlockingly engage groove 144 b andflange 146 b, which are formed in wire 34. When sleeve 142 is moved awayfrom the fastener or wire, the coupling becomes unrestrained and theflexible member and the fastener or wire can be readily separated byremoving flanges 146 a and 146 b from grooves 144 a and 144 b as shownin FIG. 11B. Member 115 may be secured to fastener wire 34 to preventthe end of coil 26 adjacent to groove 144 b and flange 146 b fromsliding thereover. Member 115 also may be described as a stopper forspring 26.

FIGS. 12A and 12B show another release mechanism, which is generallydesignated with reference numeral 29 d. In this embodiment, taperedmember 3 is provided with a bore for receiving both flexible member 19and the fastener or wire 34. Member or collar 115 may be fixedly securedto the fastener or wire 34 to resist coil movement over the wire andtoward the flexible member. The fastener or wire also may be fixedlysecured to the inner wall of tapered member 3 by, for example, gluing orwelding. One end of the flexible member is tied into a knot such as knot150. The knot is packed into the bore 152 and the tapered member isswaged or crimped as shown in FIGS. 12A and 12B to secure the knot inthe bore. The flexible member is cut as shown in FIG. 12B to decouplethe flexible member from the fastener.

FIGS. 13A and 13B illustrate a further release mechanism, which isgenerally designated with reference numeral 29 e. Release mechanism 29 egenerally comprises a release member having a cavity formed therein toreceive the fastener or wire 34 and a portion configured for severingthe fastener wire. This advantageously eliminates the need for aseparate cutting tool to separate the suture or needle from thefastener. One example of such a release member is shown as releasemember 160. Release member 160 has one end which is fixedly secured totapered member 3 to which flexible member 19 is secured. Alternatively,members 3 and 160 may be integrally formed. Release member 160 isconfigured to form a cavity 162 therein and may be in the form of asleeve. Member 160 includes annular flange 164 through which fastenerwire 34 is received. Annular flange 164 includes an annular lip 166,which forms a cutting surface or annular blade. Release member 160 alsomay include an opening for receiving flexible member 19 therethrough asshown in FIGS. 13A and 13B. In this example, release member 160 can befixedly secured to flexible member 19, which, in turn, can be fixedlysecured to tapered member 3. Of course, it should be understood thatmembers 160 and 3 can be directly secured to one another or integrallyformed as a single piece. When release member 160 is radially compressedas shown in FIG. 13B, annular lip severs fastener wire 34 and decouplesflexible member therefrom. Fastener wire 34 may be provided with annulargroove 168 to enhance wire fracture. Release member 160 or annular lip166 may be 400 series stainless steel or tool steel to facilitatehardening. Other materials that tend to provide an effective cuttingtool also may be used. Release member 160, however, should comprisematerial that provides the desired flexibility. Further, it should beunderstood that although release member 160 is shown with a generallycylindrical configuration, other configurations may be used. Inassembly, member 115, which may be annular, may be swaged, glued orwelded to wire 34 to compress coil 34 after the other end of wire hasbeen secured to a locking device or coupling so that the fastener opensas may be done in the embodiments of FIGS. 11A and B and 12A and B. Wire34 may be preformed with groove 168 or the groove formed prior tosliding member 160 over wire 34 so as to engage blade 166 with thegroove.

It is to be understood that locking devices other than those describedabove may be used without departing from the scope of the invention. Forexample, a locking device (not shown) may comprise a tubular memberhaving an opening formed in a sidewall thereof for receiving an endportion of the wire. The end of the wire may be bent so that it isbiased to fit within the opening in the sidewall of the tubular member.An instrument, such as a needle holder may then be used to push the wireaway from the opening in the tubular member and release the wire fromthe tubular member. Various other types of locking devices including aspring detent or bayonet type of device may also be used. Further, thefastener or wire end portions may be configured differently than thatshown. For example, one or both of the fastener or wire end portions maybe provided with grooves instead of enlarged portions and the releasemechanisms or locking device arms, such as, for example, fingers 81 orstrands 106, may be provided with projections to releaseably engage withthe grooves.

FIG. 14A is a front view of another embodiment of tissue connectorassembly of the present invention which is generally designated withreference numeral 211. Tissue connector assembly 211 is the same astissue connector assembly 11 with the exception that locking device orrelease mechanism 28 is directly connected to needle 16. Although any ofthe release mechanisms 28 a-c may be used to couple the fastener toneedle 16, release mechanism 28 c is shown in FIG. 14B for purposes ofillustrating a connection between a locking device and needle 16.

Referring to FIG. 14B, rod 162 extends from needle 16. Rod 162 andneedle 16 may be integrally formed or be separate elements secured whichare fixed to one another. The coupling of strands 106 to the needle ispreferably accomplished by gluing or soldering to the rod 162, althoughother equivalent or similar known joining techniques may be employed(e.g. welding, threadably attaching, etc). Similarly, when the rod andneedle are discrete elements, the rod is preferably glued, soldered orthreaded into the needle. Alternately, rod 162 may extend from or beaffixed to a transition element which in turn is affixed to needle 16.

FIG. 15 is a front view of a lateral tissue connector which is generallydesignated with reference numeral 300 and which can be used inconjunction with any of the assemblies described above as will bedescribed in detail below. Tissue connector assembly 300 generallyincludes needle 16, a locking device or release mechanism, and afastener, which may be fastener 20, 40, 41, or 43, for example. In thisembodiment, needle 16 is attached directly to a locking device, such aslocking device 28 c, a connection for which is described above withreference to FIG. 14A. FIG. 14A shows tissue connector assembly 211 withthe fastener in its open (deformed) configuration.

As noted above, tissue connector assemblies described above have manyuses. They may be especially useful for minimally invasive surgicalprocedures including creating an anastomosis between a vascular graft 12and an artery 14. The anastomosis may be used to replace or bypass adiseased, occluded or injured artery. A coronary bypass graft procedurerequires that a source of arterial blood flow be prepared for subsequentbypass connection to a diseased artery. An arterial graft may be used toprovide a source of blood flow, or a free graft may be used andconnected at the proximal end to a source of blood flow. Preferably, thesource of blood flow is one of any number of existing arteries which maybe dissected in preparation for the bypass graft procedure. In manyinstances it is preferred to use the left internal mammary artery (LIMA)or the right internal mammary artery (RIMA), for example. Other vesselswhich may be used include the saphenous vein, gastroepiploic artery inthe abdomen, radial artery, and other arteries harvested from thepatient's body as well as synthetic graft materials, such as DACRON®(polyester fibers) or GORETEX® (expanded polytetrafluoroethylene). If afree graft vessel is used, the upstream end of the dissected vessel,which is the arterial blood source, will be secured to the aorta toprovide the desired bypass blood flow, as is well known by those skilledin the art. The downstream end of the graft vessel is trimmed forattachment to an artery, such as the left anterior descending coronary(LAD). It is to be understood that the anastomosis may be formed inother vessels or tissue.

FIGS. 16A-16D diagrammatically illustrate a method of aligning andconnecting graft and target vessels, such as connecting a graft vessel12 to an artery 14 (target vessel) using tissue connector assemblies 11and 300. In this example, two tissue connector assemblies 11 are used tomake connections at generally opposite sides of the graft vessel andtissue connector assemblies 300 are used to make connections betweenthose made with assemblies 11. The procedure may be accomplished with abeating heart procedure with the use of a heart stabilizer to keep theheart stable, for example. The procedure may also be performedendoscopically. It also should be understood that tissue connectorassemblies 211 may be substituted for assemblies 11.

The patient is first prepped for standard cardiac surgery. Afterexposure and control of artery 14, occlusion and reperfusion may beperformed as required, an arteriotomy is performed on artery 14 toprovide an opening 120 for receiving a graft vessel. After the snaredgraft vessel 12 has been prepared as would be apparent to one ofordinary skill in the art, a tissue connector assembly 11 is attached tothe free end of the graft vessel along an edge margin of the vessel. Inorder to attach the connector assembly 11, the surgeon grasps needle 16with a needle holder (e.g., surgical pliers, forceps, or any othersuitable instrument) and inserts needle 16 into the tissue of graftvessel 12 in a direction from the interior of the vessel to the exteriorof the vessel. The surgeon then releases the needle 16 and grasps aforward end of the needle which is now located outside graft vessel 12and pulls the needle and a portion of suture 18 through the vessel.Needle 17 is passed through opening 120 formed in the sidewall of theartery 14 and inserted into the tissue of the artery in a direction fromthe interior of the artery to the exterior of the artery. The surgeonthen grasps needle 17 located outside the artery 14 and pulls the needleand a portion of suture 19 through the arterial wall. A second tissueconnector assembly 11 may be inserted as described above at a locationgenerally 180 degrees from the location of the first tissue connector ina conventional “heel and toe” arrangement.

Once the tissue connector assemblies 11 are inserted, graft vessel 12 ispositioned above and aligned with opening 120 in the sidewall of theartery 14 (FIG. 16A). A section of each assembly is located betweengraft vessel 12 and artery 14. The needles 16 and 17 are pulledgenerally away from the artery 14 to reduce the length of the sutures 18and 19 (eliminate slack of the sutures) between vessel 12 and artery and“parachute” the vessel onto the artery (FIG. 16B). The needles 17 arethen pulled away from the artery 14 until each fastener 20 is positionedwithin the target vessel 14 as shown in FIG. 16B. Needles 16 are thenpulled away from graft 12 until the fasteners are positioned with oneend of each fastener 20 extending from the vessel and the opposite endof each fastener extending from the artery (FIG. 16C). The edges of thegraft vessel 12 and artery 14 are positioned adjacent one another toform a continuous interior and exterior surface along the matingportions of the vessel and artery. As shown in FIG. 16F, the tissue iscompressed within the fastener 20.

A surgical instrument (e.g., needle holder) is used to radially squeezeeach locking device 28 to release the locking device from the fastener20. Upon removal of each locking device 28, each coil 26 moves to itsfree uncompressed state which allows fastener wire 34 to return to itsoriginal undeformed closed position (FIG. 16D). As the wires 34 move totheir closed position the adjacent tissues of the graft vessel 12 andartery 14 which were previously pulled together during the parachutingof the graft vessel onto the artery, are squeezed together to securelyengage the graft vessel and artery (FIGS. 16E and 16F). It should benoted that as each locking device 28 is squeezed at least two steps areaccomplished. The fastener 20 is released from locking device 28, thusallowing coil 26 to uncompress and the wire 34 to move to its closedconfiguration, and the needle 16 is released from the fastener. Thus,any of the locking devices 28 described above provides for simultaneousactuating closure of the fastener 20 and release of the needle 16 fromthe fastener. Further, radially compression of release mechanisms 29releases needles 17 and sutures 19 from the fasteners. However, if oneof the synchronous release systems described with reference to FIGS.10A-10F is used, radial compression of a locking device 28 device willeffect essentially simultaneous closure actuation of a respectivefastener and release of needles 16 and 17 and sutures 18 and 19.

The tissue connector assemblies 300 are subsequently inserted atcircumferentially spaced locations around the periphery of the graftvessel to sealingly fasten graft vessel 12 to artery 14. Needle 16 offastener 300 is inserted into graft vessel 12 from the exterior surfaceof the graft vessel and pushed through the graft vessel and artery 14tissue. The needle holder is then used to pull the needle 16 through thearterial wall. An instrument (same needle holder or other suitableinstrument) is used to apply a squeezing force to the locking device 28to release fastener 20 from needle 16. This allows coil 26 to move toits uncompressed configuration and the wire to move to its closedposition. It should be noted that the tissue connector assemblies 11 mayremain with their fasteners in their open position while tissueconnector assemblies 300 are inserted into the tissue and moved to theirclosed position. The locking devices 28 of the tissue connectorassemblies 11 may subsequently be removed from the fasteners 20 to allowthe fasteners to move to their closed position. The number andcombination of tissue connector assemblies 11 and 300 required tosealingly secure the connecting tissues together may vary. For example,only tissue connector assemblies 11 may be used to complete the entireanastomosis.

Although coils 26 are shown remaining on the fastener or wire (FIG.16D), it is to be understood that coils 26 may also be removed fromwires 34, leaving only the wires in the connected tissue.

As an alternative to inserting tissue connector assemblies 11 at “heeland toe” locations described above, a number of tissue connectorassemblies 11 may be inserted generally around the location of the heel.The graft vessel may then be pulled towards the artery to determinewhether the opening formed in the sidewall of the artery is large enoughbefore completing the anastomosis. It also should be understood thattissue connector assemblies 211 may be used instead of or in conjunctionwith assemblies 11.

Although the suturing procedure has been described for an end-to-sideanastomosis, it should be appreciated that the procedure is applicableto an end-to-end and side-to-side anastomosis, connecting various tissuestructures including single and multiple tissue structures, and puncturesites, and connecting tissue to a prosthetic graft or valve, forexample.

It will be observed from the foregoing that the tissue connectorassemblies of the present invention have numerous advantages.Importantly, the assemblies are easier and faster to apply thanconventional sutures which require tying multiple knots. The assembliesalso may be used in minimally invasive procedures including endoscopicprocedures.

All references cited above are incorporated herein by reference.

The above is a detailed description of particular embodiments of theinvention. It is recognized that departures from the disclosedembodiments may be made within the scope of the invention and thatobvious modifications will occur to a person skilled in the art. Thefull scope of the invention is set out in the claims that follow andtheir equivalents. Accordingly, the claims and specification should notbe construed to unduly narrow the full scope of protection to which theinvention is entitled.

What is claimed is:
 1. A tissue connector assembly comprising a surgicalfastener having an unbiased loop configuration, a first tissue piercingmember and a second tissue piercing member, said surgical fastenerhaving a first end portion and a second end portion, said first tissuepiercing member being coupled to said first end portion and said secondtissue piercing member being coupled to said second end portion, furtherincluding a flexible member, said flexible member having a first endportion coupled to said first tissue piercing member and a second endportion coupled to said first end portion of said fastener.
 2. Thetissue connector assembly of claim 1 further including a second flexiblemember, said second flexible member having a first end portion coupledto said second tissue piercing member and a second end portion coupledto said second end portion of said fastener.
 3. The tissue connectorassembly of claim 2 wherein said first flexible member comprises asuture.
 4. The tissue connector assembly of claim 2 wherein each of saidflexible members comprises a suture.
 5. The tissue connector assembly ofclaim 2 wherein at least one of said flexible members comprises metal.6. The tissue connector assembly of claim 1 wherein said flexible membercomprises a suture.
 7. The tissue connector assembly of claim 1 whereinsaid flexible member comprises metal.
 8. The tissue connector assemblyof claim 1 wherein at least one of said tissue piercing memberscomprises a needle.
 9. The tissue connector assembly of claim 1 whereineach of said tissue piercing members comprises a needle.
 10. The tissueconnector assembly of claim 1 further including a coupling, said firsttissue piercing member and said end portion of said surgical fastenerbeing coupled to said coupling.
 11. The tissue connector assembly ofclaim 10 wherein said coupling comprises a tubular member having movableportions and said surgical fastener includes an enlarged portion adaptedfor receipt in said movable portions.
 12. The tissue connector assemblyof claim 11 wherein said enlarged portion is spherical.
 13. The tissueconnector assembly of claim 11 wherein said movable portions comprise aplurality of strands.
 14. The tissue connector assembly of claim 13wherein a plurality of said strands include a notch for receiving aportion of said enlarged portion.
 15. The tissue connector assembly ofclaim 13 wherein said strands comprise wires.
 16. The tissue connectorassembly of claim 13 wherein said strands comprise cables.
 17. Thetissue connector assembly of claim 10 including a second coupling, saidsurgical fastener second end portion second piercing member beingcoupled to said second coupling.
 18. The tissue connector assembly ofclaim 17 wherein said surgical fastener includes an enlarged portion andsaid second coupling comprises a generally tubular member having movableportions adapted to receive at least a portion of said second portion.19. The tissue connector assembly of claim 18 wherein said movableportions comprise a plurality of strands.
 20. The tissue connectorassembly of claim 18 wherein a plurality of said strands include a notchfor receiving a portion of said enlarged portion.
 21. The tissueconnector assembly of claim 17 wherein said second coupling releases thecoupling between said second piercing member and said surgical fastenerin response to releasing said fastener first end portion coupling. 22.The tissue connector assembly of claim 17 further including a coilsurrounding said surgical fastener and wherein said fastener includesfirst and second enlarged portions and said fastener first end portioncoupling and said second coupling are adapted for receipt of saidfastener first and second enlarged portions, respectively, said secondcoupling including members having portions that have a radially outwardbias and extend within said coil when said coil is compressed againstsaid second coupling.
 23. The tissue connector assembly of claim 17wherein said fastener includes a groove and projection and said secondcoupling includes a member having a groove and projection and a sleeveslidably mounted thereon, said fastener groove and projection beingconfigured to mate with said coupling member groove and projection. 24.The tissue connector assembly of claim 17 further including a flexiblemember having a portion coupled to said second tissue piercing memberand a knotted portion, said second coupling including a tubular memberhaving a bore, said knotted portion being in said bore and said borehaving a portion with a diameter less than that of a section of saidknotted portion.
 25. The tissue connector assembly of claim 17 whereinsaid second coupling comprises an annular blade coupled to said secondpiercing member, said annular blade surrounding and being secured to aportion of said surgical fastener.
 26. The tissue connector assembly ofclaim 1 wherein said surgical fastener comprises a surgical clip. 27.The tissue connector assembly of claim 26 wherein said surgical clipcomprises a wire.
 28. The tissue connector assembly of claim 27 furtherincluding a coil surrounding at least a portion of said wire and havingconfined ends.
 29. The tissue connector assembly of claim 28 whereinsaid wire comprises shape memory material.
 30. The tissue connectorassembly of claim 29 wherein said surgical clip has an openconfiguration and a closed configuration.
 31. The tissue connectorassembly of claim 30 wherein said surgical clip is in said closedconfiguration when in a relaxed state.
 32. The tissue connector assemblyof claim 30 wherein said surgical clip is generally U-shaped when insaid open configuration.
 33. The tissue connector assembly of claim 30wherein said surgical clip assumes a spiral configuration when in saidclosed configuration.
 34. A tissue connector assembly comprising asurgical fastener having an unbiased loop configuration, a first tissuepiercing member and a second tissue piercing member, said surgicalfastener having a first end portion and a second end portion, said firsttissue piercing member being coupled to said first end portion and saidsecond tissue piercing member being coupled to said second end portion,said assembly further including a coupling, said first tissue piercingmember and said first end portion of said surgical fastener beingcoupled to said coupling, said assembly including a second coupling,said surgical fastener second end portion and second piercing memberbeing coupled to said second coupling, the assembly further including aflexible member and a coil, said flexible member having a portioncoupled to said second tissue piercing member and a portion coupled tosaid second coupling, said coil surrounding said surgical fastener andbeing compressed against said second coupling, said fastener includingan enlarged portion and said fastener first end portion coupling beingadapted for receipt of said enlarged portion, said second couplingincluding a first member fixedly secured to said fastener and a secondmember slidably coupled to said fastener, and said flexible member beingcompressed between said second coupling members when said coil iscompressed against said slidably coupled member.
 35. A tissue connectorassembly comprising a surgical fastener having first and second endportions, a first tissue piercing member, a second tissue piercingmember, and at least one flexible member having first and second endportions, said at least one flexible member first end portion beingattached to said first tissue piercing member, said at least oneflexible member second end portion being coupled to said first endportion of said surgical fastener, said second end portion of saidsurgical fastener being coupled to said second tissue piercing member.36. The tissue connector assembly of claim 35 wherein said at least oneflexible member comprises a suture.
 37. The tissue connector assembly ofclaim 35 wherein said at least one flexible member comprises metal. 38.The tissue connector assembly of claim 35 further including a coupling,said flexible member and surgical fastener being secured to saidcoupling.
 39. The tissue connector assembly of claim 38 wherein saidcoupling and flexible member have outer surfaces, said coupling andflexible member being configured to form a smooth, continuous transitionthere between along said outer surfaces.
 40. The tissue connectorassembly of claim 38 wherein said coupling and flexible member form aninterface, at least a portion of each of said coupling and flexiblemember adjacent to said interface having the same cross-sectional shapeand dimension.
 41. The tissue connector assembly of claim 38 whereinsaid coupling and flexible member have essentially the samecross-sectional shape and dimension.
 42. The tissue connector assemblyof claim 38 wherein said surgical fastener is releasably coupled to saidcoupling.
 43. The tissue connector assembly of claim 38 wherein saidsurgical fastener includes an enlarged portion and said couplingcomprises a tubular member having movable portions adapted to receive atleast a portion of said enlarged portion.
 44. The tissue connectorassembly of claim 43 wherein said enlarged portion is spherical.
 45. Thetissue connector assembly of claim 43 wherein said movable portionscomprises a plurality of strands.
 46. The tissue connector assembly ofclaim 45 wherein a plurality of said strands include a notch forreceiving a portion of said enlarged portion.
 47. The tissue connectorassembly of claim 45 wherein said strands comprise wires.
 48. The tissueconnector assembly of claim 45 wherein said strands comprise cables. 49.The tissue connector assembly of claim 38 including a second coupling,said surgical fastener second end portion and second piercing memberbeing coupled to said second coupling.
 50. The tissue connector assemblyof claim 49 wherein said surgical fastener includes a first and secondenlarged portion and each of said couplings comprise a generally tubularmember having movable portions adapted to receive at least a portion ofone of said enlarged portion.
 51. The tissue connector assembly of claim50 wherein said movable portions comprise a plurality of strands. 52.The tissue connector assembly of claim 50 wherein a plurality of saidstrands include a notch for receiving a portion of said enlargedportions.
 53. The tissue connector assembly of claim 49 wherein saidsecond coupling releases the coupling between said second piercingmember and said surgical fastener in response to releasing said fastenerfirst end portion coupling.
 54. The tissue connector assembly of claim49 further including a coil surrounding said surgical fastener andwherein said fastener includes first and second enlarged portions andsaid fastener first end portion coupling and said second coupling areadapted for receipt of said fastener first and second enlarged portions,respectively, said second coupling including member that are biasedradially outward with portions extending within said coil when said coilis compressed against said second coupling.
 55. The tissue connectorassembly of claim 49 further including a second flexible member and acoil, said second flexible member having a portion coupled to saidsecond tissue piercing member and a portion coupled to said secondcoupling, said coil surrounding said surgical fastener and beingcompressed against said second coupling, said fastener including anenlarged portion and said fastener first end portion coupling beingadapted for receipt of said enlarged portion, said second couplingincluding a first member fixedly secured to said fastener and a secondmember slidably coupled to said fastener, and said flexible member beingcompressed between said second coupling members when said coil iscompressed against said slidably coupled member.
 56. The tissueconnector assembly of claim 49 wherein said fastener includes a grooveand projection and said second coupling includes a member having agroove and projection and a sleeve slidably mounted thereon, saidfastener groove and projection being configured to mate with saidcoupling member groove and projection.
 57. The tissue connector assemblyof claim 49 further including a second flexible member having a portioncoupled to said second tissue piercing member and a knotted portion,said second coupling including a tubular member having a bore, saidknotted portion being in said bore and said bore having a portion with adiameter less than that of a section of said knotted portion.
 58. Thetissue connector assembly of claim 49 wherein said second couplingcomprises an annular blade coupled to said second piercing member, saidannular blade surrounding and being secured to a portion of saidsurgical fastener.
 59. The tissue connector assembly of claim 35 whereinsaid surgical fastener comprises a surgical clip.
 60. The tissueconnector assembly of claim 59 wherein said surgical clip comprises awire.
 61. The tissue connector assembly of claim 60 further including acoil surrounding at least a portion of said wire and having confinedends.
 62. The tissue connector of claim 61 wherein said wire comprisesshape memory material.
 63. The tissue connector assembly of claim 62wherein said surgical clip has an open configuration and a closedconfiguration.
 64. The tissue connector assembly of claim 63 whereinsaid surgical clip is in said closed configuration when in a relaxedstate.
 65. The tissue connector assembly of claim 63 wherein saidsurgical clip is generally U-shaped when in said open configuration. 66.The tissue connector assembly of claim 63 wherein said surgical clipassumes a spiral configuration when in said closed configuration.
 67. Atissue connector assembly comprising two needles, a surgical clip and aflexible member having a portion releaseably coupled to said surgicalclip and a portion coupled to one of said needles, the other one of saidneedles being coupled to said surgical clip.
 68. The tissue connectorassembly of claim 67 further comprising a second flexible member havinga portion releaseably coupled to said surgical clip and a portioncoupled to said other one of said needles.
 69. The tissue connectorassembly of claim 67, wherein said surgical clip comprises a wire andsaid assembly further includes a coil surrounding at lest a portion ofsaid wire and having confined ends.
 70. The tissue connector assembly ofclaim 69 wherein said wire comprises shape memory material and has anopen configuration and a closed configuration in the form of a loop. 71.A method of setting a tissue connector assembly including a surgicalfastener and multiple discrete tissue piercing members coupled theretocomprising manipulating a single portion of the tissue connectorassembly to both release the tissue piercing members from the fastenerand actuate closure of the fastener.
 72. A method of securing portionsof material together, at least one of which comprises tissue, the methodcomprising placing at least a portion of a first piercing member, havinga surgical fastener coupled thereto, in a vessel lumen, placing at leasta portion of a second piercing member, which also is coupled to thesurgical fastener and where at least one of the piercing members iscoupled to the surgical fastener with a flexible member, in a tubulargraft, passing the first piercing member through the wall of the vesselfrom an interior surface thereof, passing the second piercing memberthrough the wall of the tubular graft from an interior surface thereof,and positioning the fastener with one portion thereof extending throughsaid vessel wall and another portion extending through said graft wall.73. The method of claim 72 wherein the flexible member is selected to bea suture.
 74. The method of claim 72 wherein all of the at least oneflexible member and the piercing members are removed from the fastener.75. Tissue connector apparatus for connecting at least two structures,said apparatus comprising: a surgical clip adapted to connect the atleast two structures together, said clip having first and second endportions and being constructed for movement from an open configurationto a closed configuration; a flexible member having a first end and asecond end, said second end coupled to said first end portion of saidsurgical clip; a first needle secured to said first end of said flexiblemember; and a second needle having a first end and a second end, saidsecond needle second end being coupled to said surgical clip secondportion.
 76. The tissue connector apparatus of claim 75 wherein saidclip is adapted to connect structures selected from the group consistingof tissue, prostheses, and graft materials.
 77. The tissue connectorapparatus of claim 75 wherein said clip comprises a wire.
 78. The tissueconnector apparatus of claim 77 wherein said wire comprises nitinol. 79.The tissue connector apparatus of claim 75 further including a coilsurrounding at least a portion of said clip.
 80. The tissue connectorapparatus of claim 79 further including a coil restraint at one of theend portions of said clip for limiting movement of said coil relative tosaid clip.
 81. The tissue connector apparatus of claim 80 wherein saidclip has an enlarged portion which forms said coil restraint.
 82. Thetissue connector apparatus of claim 80 further including a second coilrestraint at said second end portion of said clip for limiting relativemovement between said coil and said clip.
 83. The tissue connectorapparatus of claim 82 wherein said restraints each form an enlargedportion on said clip.
 84. The tissue connector apparatus of claim 82wherein said coil has first and second ends, at least one end of saidcoil being slidably movable along said clip.
 85. The tissue connectorapparatus of claim 82 further comprising a coupling that releasablycouples said clip first end portion to said flexible member.
 86. Thetissue connector apparatus of claim 85 further comprising a secondcoupling that releasably couples said clip second end portion to saidsecond needle.
 87. The tissue connector apparatus of claim 82 furtherincluding a second flexible member, said second flexible member beingsecured to said second needle and releasably coupled to said clip. 88.The tissue connector apparatus of claim 87 wherein said first and secondflexible members each comprise a suture.
 89. The tissue connectorapparatus of claim 87, further comprising first and second couplings,said second coupling releasably coupling said clip second end portion tosaid second flexible member and said first coupling releasably couplingsaid clip first end portion to the other of said flexible members. 90.The tissue connector apparatus of claim 89 wherein said surgical clipcomprises shape memory material and is adapted to assume said closedconfiguration.
 91. Tissue connector apparatus comprising a surgicalclip, first and second needles each having first and second endportions, first and second couplings, and first and second flexiblemembers, said surgical clip adapted to connect at least two structurestogether and constructed for movement from an open configuration to aclosed configuration, said surgical clip having first and second endportions, said first coupling being releasably coupled to said first endportion of said surgical clip and said second coupling being releasablycoupled to said second end portion of said surgical clip, said firstflexible member having a first end portion coupled to said firstcoupling and a second end portion secured to said second end portion ofsaid first needle, and said second flexible member having a first endportion coupled to said second coupling and a second end portion securedto said second end portion of said second needle.
 92. The tissueconnector apparatus of claim 91 wherein said surgical clip comprisesshape memory material and is adapted to assume a loop configuration. 93.The tissue connector apparatus of claim 91 including a coil surroundingat least a portion of said surgical clip and being restrained betweensaid first and second couplings.